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Various Smith & Nephew, Inc. Sterilization and Stabilization Kits (2017-03-05)
- Starting date:
- March 5, 2017
- Posting date:
- April 13, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62958
Affected Products
- Disposable Face Mask
- Kit Stabilization Shoulder
- Kit Stabilization Elbow
- Small Wrist Stabilization Kits
- Spider Ankle Stabilization Kits
- Leg Stabilization Kits Tenet
- Switch Drape Tenet
- Spider2 Shoulder Stabilization Kit
Reason
The provided label does not reflect the current legal manufacturer and when applicable, the current CE mark. The product label incorrectly lists tenet medical engineering as the legal manufacturer, with tenet CE mark when applicable, as opposed to smith & nephew. The labeling error is not obvious to the user.
Affected products
A. Disposable Face Mask
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 7210559
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
B. Kit Stabilization Shoulder
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 7210573
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
C. Kit Stabilization Elbow
Lot or serial number
- 20151015
Model or catalog number
- 7210574
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
D. Small Wrist Stabilization Kits
Lot or serial number
- D160701
Model or catalog number
- 72201550
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
E. Spider Ankle Stabilization Kits
Lot or serial number
- 20151010
Model or catalog number
- 72202931
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
F. Leg Stabilization Kits Tenet
Lot or serial number
- 20150923
- 20151025
- 20160119
Model or catalog number
- 72203238
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
G. Switch Drape Tenet
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 72203300
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
H. Spider2 Shoulder Stabilization Kit
Lot or serial number
- 20150805
Model or catalog number
- 72203833
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES